Brachial Plexus Birth PalsyNCT07654504
Validity and Reliability of the Turkish Version of the Impact of Brachial Plexus Injury Questionnaire (IMBPIQ)
An observational study of Brachial Plexus Birth Palsy and Brachial Plexus Palsy, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this methodological study is to translate the Impact of Brachial Plexus Injury Questionnaire (IMBPIQ) into Turkish, culturally adapt it, and evaluate its validity and reliability for use in adults with brachial plexus birth palsy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brachial Plexus Birth Palsy, Brachial Plexus Palsy, Brachial Plexus Palsy Due to Birth Trauma
- What is being tested?
- Questionnaire Assessment Battery
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2026to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of adults aged 18 years and older with a diagnosis of brachial plexus birth palsy who are able to read, write, speak, and understand Turkish. Participants will be recruited on a voluntary basis from individuals with brachial plexus birth palsy who meet the eligibility criteria. Both female and male participants will be included.
Who may be able to join
- Being 18 years of age or older.
- Having a diagnosis of brachial plexus birth palsy.
- Having the ability to read, write, speak, and understand Turkish.
- Agreeing to participate voluntarily in the study and signing the informed consent form.
Who cannot join
- Having a neurological disease.
- Having another orthopedic problem or a history of trauma in the affected upper extremity.
- Having a severe cognitive or communication impairment that may prevent completion of the questionnaires or understanding of the study instructions.
- Having a history of systemic disease requiring an acute attack or hospitalization within the last three months.
- Being pregnant or being in the postpartum period of less than 6 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Biruni University
Istanbul, Istanbul, 34015
Fahri Dogukan Bozkurt, Physiotherapist, MSc Student, +905392870087, fahrib@biruni.edu.tr
Zeynep Hosbay, Physiotherapist, Prof., +905055034279, zhosbay@biruni.edu.tr
About this study
The aim of this methodological study is to translate the Impact of Brachial Plexus Injury Questionnaire (IMBPIQ) into Turkish, culturally adapt it, and evaluate its validity and reliability for use in adults with brachial plexus birth palsy. The study will include 50 adult participants aged 18 years and older with a diagnosis of brachial plexus birth palsy. Participants will complete the Turkish version of the IMBPIQ, as well as the Disabilities of the Arm, Shoulder and Hand questionnaire and the Short Form-36. The psychometric properties of the Turkish IMBPIQ will be examined using reliability and validity analyses, including internal consistency, test-retest reliability, and construct validity.
Read the detailed description
The Impact of Brachial Plexus Injury Questionnaire (IMBPIQ) is a disease-specific patient-reported outcome measure developed to evaluate the impact of brachial plexus injury on daily life, functional status, and psychosocial well-being. There is currently no Turkish version of the IMBPIQ with established validity and reliability. Considering the increasing importance of culturally adapted patient-reported outcome measures, this study aims to translate the IMBPIQ into Turkish, perform its cultural adaptation, and evaluate the validity and reliability of the Turkish version for use in adults with brachial plexus birth palsy.
This study is designed as a methodological validity and reliability study. Written permission has been obtained from the original developers of the IMBPIQ for translation, cultural adaptation, and psychometric testing. The English version of the questionnaire will be translated into Turkish by independent translators. The translated versions will be reviewed by a committee, and a single Turkish version will be created based on consensus. This Turkish version will then be back-translated into English by a translator whose native language is English and who is proficient in both languages. The original version and the back-translated version will be compared in terms of semantic equivalence, linguistic appropriateness, and cultural adaptation, and the final Turkish version of the questionnaire will be established.
A pilot test will be conducted with 10 participants to evaluate the comprehensibility and applicability of the Turkish version of the questionnaire. Based on the feedback obtained from the pilot test, final revisions will be made before the main study. The main study will include 50 adult participants aged 18 years and older with a diagnosis of brachial plexus birth palsy. Participants will complete a sociodemographic and clinical information form, the Turkish version of the IMBPIQ, the Disabilities of the Arm, Shoulder and Hand questionnaire, and the Short Form-36.
The IMBPIQ consists of 43 items and includes four main subdomains: symptoms, limitations, emotional status, and expected or achieved improvement after surgery or treatment. Raw scores obtained from the responses are converted into normalized standard scores ranging from 0 to 100. The disability domain score is calculated using the symptoms, limitations, and emotional status subdomains, with higher scores indicating greater disability and psychosocial impact. The improvement domain score reflects the expected or achieved improvement related to surgery or treatment, with higher scores indicating greater expected or perceived improvement.
The Disabilities of the Arm, Shoulder and Hand questionnaire will be used to evaluate upper extremity symptoms and functional disability. The Short Form-36 will be used to assess health-related quality of life. These measures will be used to examine the construct validity of the Turkish IMBPIQ through correlations with related patient-reported outcome measures.
Statistical analyses will be performed using IBM SPSS Statistics software. Descriptive statistics will be calculated to summarize participants' sociodemographic and clinical characteristics. Internal consistency reliability will be evaluated using Cronbach's alpha coefficient. Test-retest reliability will be examined by re-administering the Turkish IMBPIQ to 30 participants after a two-week interval, and agreement between the two assessments will be analyzed using the intraclass correlation coefficient. Construct validity will be assessed using Pearson or Spearman correlation analyses between the IMBPIQ scores and the scores obtained from the Disabilities of the Arm, Shoulder and Hand questionnaire and the Short Form-36. The statistical significance level will be accepted as p < 0.05.
- Conditions
- Brachial Plexus Birth Palsy, Brachial Plexus Palsy, Brachial Plexus Palsy Due to Birth Trauma, Obstetric Brachial Plexus Injury
- Being tested
- Questionnaire Assessment Battery
- Keywords
- Impact of Brachial Plexus Injury Questionnaire, IMBPIQ, Brachial Plexus Birth Palsy, Obstetric Brachial Plexus Palsy, Turkish Version, Validity, Reliability, Cultural Adaptation, Patient-Reported Outcome Measure, DASH, Short Form-36, Test-Retest Reliability, Internal Consistency, Construct Validity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire Assessment BatteryOther
Participants will complete the Turkish version of the Impact of Brachial Plexus Injury Questionnaire, the Disabilities of the Arm, Shoulder and Hand questionnaire, and the Short Form-36.
| Study group | Role | What they receive |
|---|---|---|
| Adults With Brachial Plexus Birth Palsy | Adults aged 18 years and older with a diagnosis of brachial plexus birth palsy who will complete the Turkish version of the Impact of Brachial Plexus Injury Questionnaire and related assessment tools. Receives: Other: Questionnaire Assessment Battery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity and Reliability of the Turkish IMBPIQ
The validity and reliability of the Turkish version of the Impact of Brachial Plexus Injury Questionnaire will be evaluated. Reliability will be assessed using internal consistency and test-retest reliability analyses. Validity will be assessed using construct validity analyses through correlations with related patient-reported outcome measures.
Measured: Baseline and after 1 week
Secondary outcomes (2)
Upper Extremity Disability
Upper extremity disability will be assessed using the Disabilities of the Arm, Shoulder and Hand questionnaire. Higher scores indicate greater upper extremity disability.
Measured: Baseline
Health-Related Quality of Life
Health-related quality of life will be assessed using the Short Form-36. The scale includes subdomains related to physical and mental health, with higher scores indicating better health status.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brachial Plexus Birth PalsyStudies of the same condition, open and under way.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fahri Doğukan Bozkurt, Biruni University
- Investigators
- Zeynep Hosbay, Physiotherapist, Prof., Study director, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07654504
- Sponsor's protocol ID
- 2024-BİAEK/19-38
- Status last verified
- Jun 2026
- First submitted
- 13 Jun 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared in order to protect participant privacy, confidentiality, and ethical data protection principles.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of the Turkish Version of the Impact of Brachial Plexus Injury Questionnaire (IMBPIQ)
- ClinicalTrials.gov ID
- NCT07654504
- Acronym / sponsor ID
- 2024-BİAEK/19-38
- Conditions
- Brachial Plexus Birth Palsy, Brachial Plexus Palsy, Brachial Plexus Palsy Due to Birth Trauma, Obstetric Brachial Plexus Injury
- Keywords
- Impact of Brachial Plexus Injury Questionnaire, IMBPIQ, Brachial Plexus Birth Palsy, Obstetric Brachial Plexus Palsy, Turkish Version, Validity, Reliability, Cultural Adaptation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this methodological study is to translate the Impact of Brachial Plexus Injury Questionnaire (IMBPIQ) into Turkish, culturally adapt it, and evaluate its validity and reliability for use in adults with brachial plexus birth palsy. The study will include 50 adult participants aged 18 years and older with a diagnosis of brachial plexus birth palsy. Participants will complete the Turkish version of the IMBPIQ, as well as the Disabilities of the Arm, Shoulder and Hand questionnaire and the Short Form-36. The psychometric properties of the Turkish IMBPIQ will be examined using reliability and validity analyses, including internal consistency, test-retest reliability, and construct validity.
Detailed description
The Impact of Brachial Plexus Injury Questionnaire (IMBPIQ) is a disease-specific patient-reported outcome measure developed to evaluate the impact of brachial plexus injury on daily life, functional status, and psychosocial well-being. There is currently no Turkish version of the IMBPIQ with established validity and reliability. Considering the increasing importance of culturally adapted patient-reported outcome measures, this study aims to translate the IMBPIQ into Turkish, perform its cultural adaptation, and evaluate the validity and reliability of the Turkish version for use in adults with brachial plexus birth palsy.
This study is designed as a methodological validity and reliability study. Written permission has been obtained from the original developers of the IMBPIQ for translation, cultural adaptation, and psychometric testing. The English version of the questionnaire will be translated into Turkish by independent translators. The translated versions will be reviewed by a committee, and a single Turkish version will be created based on consensus. This Turkish version will then be back-translated into English by a translator whose native language is English and who is proficient in both languages. The original version and the back-translated version will be compared in terms of semantic equivalence, linguistic appropriateness, and cultural adaptation, and the final Turkish version of the questionnaire will be established.
A pilot test will be conducted with 10 participants to evaluate the comprehensibility and applicability of the Turkish version of the questionnaire. Based on the feedback obtained from the pilot test, final revisions will be made before the main study. The main study will include 50 adult participants aged 18 years and older with a diagnosis of brachial plexus birth palsy. Participants will complete a sociodemographic and clinical information form, the Turkish version of the IMBPIQ, the Disabilities of the Arm, Shoulder and Hand questionnaire, and the Short Form-36.
The IMBPIQ consists of 43 items and includes four main subdomains: symptoms, limitations, emotional status, and expected or achieved improvement after surgery or treatment. Raw scores obtained from the responses are converted into normalized standard scores ranging from 0 to 100. The disability domain score is calculated using the symptoms, limitations, and emotional status subdomains, with higher scores indicating greater disability and psychosocial impact. The improvement domain score reflects the expected or achieved improvement related to surgery or treatment, with higher scores indicating greater expected or perceived improvement.
The Disabilities of the Arm, Shoulder and Hand questionnaire will be used to evaluate upper extremity symptoms and functional disability. The Short Form-36 will be used to assess health-related quality of life. These measures will be used to examine the construct validity of the Turkish IMBPIQ through correlations with related patient-reported outcome measures.
Statistical analyses will be performed using IBM SPSS Statistics software. Descriptive statistics will be calculated to summarize participants' sociodemographic and clinical characteristics. Internal consistency reliability will be evaluated using Cronbach's alpha coefficient. Test-retest reliability will be examined by re-administering the Turkish IMBPIQ to 30 participants after a two-week interval, and agreement between the two assessments will be analyzed using the intraclass correlation coefficient. Construct validity will be assessed using Pearson or Spearman correlation analyses between the IMBPIQ scores and the scores obtained from the Disabilities of the Arm, Shoulder and Hand questionnaire and the Short Form-36. The statistical significance level will be accepted as p < 0.05.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults With Brachial Plexus Birth Palsy | – | Other: Questionnaire Assessment BatteryAdults aged 18 years and older with a diagnosis of brachial plexus birth palsy who will complete the Turkish version of the Impact of Brachial Plexus Injury Questionnaire and related assessment tools. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adults aged 18 years and older with a diagnosis of brachial plexus birth palsy who are able to read, write, speak, and understand Turkish. Participants will be recruited on a voluntary basis from individuals with brachial plexus birth palsy who meet the eligibility criteria. Both female and male participants will be included.
Key inclusion criteria (4 listed)
- Being 18 years of age or older.
- Having a diagnosis of brachial plexus birth palsy.
- Having the ability to read, write, speak, and understand Turkish.
- Agreeing to participate voluntarily in the study and signing the informed consent form.
Key exclusion criteria (5 listed)
- Having a neurological disease.
- Having another orthopedic problem or a history of trauma in the affected upper extremity.
- Having a severe cognitive or communication impairment that may prevent completion of the questionnaires or understanding of the study instructions.
- Having a history of systemic disease requiring an acute attack or hospitalization within the last three months.
- Being pregnant or being in the postpartum period of less than 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire Assessment BatteryParticipants will complete the Turkish version of the Impact of Brachial Plexus Injury Questionnaire, the Disabilities of the Arm, Shoulder and Hand questionnaire, and the Short Form-36. | Other | Adults With Brachial Plexus Birth Palsy |
Primary outcome
Validity and Reliability of the Turkish IMBPIQ
Time frame: Baseline and after 1 week
The validity and reliability of the Turkish version of the Impact of Brachial Plexus Injury Questionnaire will be evaluated. Reliability will be assessed using internal consistency and test-retest reliability analyses. Validity will be assessed using construct validity analyses through correlations with related patient-reported outcome measures.
2 secondary outcomes
Upper Extremity Disability
Time frame: Baseline
Health-Related Quality of Life
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared in order to protect participant privacy, confidentiality, and ethical data protection principles.
Related trials for Brachial Plexus Birth Palsy
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Constraint Therapy for Brachial Plexus Birth Injury
Brachial Plexus Birth Palsy
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Investigation of the Relationship Between Shoulder Alpha Angle and Humeral Head Displacement Percentage Measured by Ultrasonography in Neonatal Brachial Plexus Palsy Infants With Clinical Parameters
Glenohumeral Subluxation, Neonatal Brachial Plexus Palsy
Enrolling by invitation
Virtual Reality and Dual-Task Training for Cortical Plasticity in Children With Brachial Plexus Injury
Brachial Plexus Birth Palsy, Physical Therapy
RecruitingObservational study
Evaluation of Pain, Upper Extremity Function, and Social Appearance Anxiety in Adults With Obstetric Brachial Plexus Palsy Who Underwent Shoulder Tendon Transfer Surgery
Brachial Plexus Birth Palsy, Brachial Plexus Palsy
RecruitingPhase 3
Effectiveness and Safety of Early Intramuscular Botulinum Toxin Injections to Prevent Shoulder Deformity in Babies With Obstetrical Brachial Plexus Palsy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zeynep Hosbay, Physiotherapist, Prof. study director
Biruni University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brachial Plexus Birth Palsy and Brachial Plexus Palsy, run by Biruni University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fahri Dogukan Bozkurt, Physiotherapist, MSc Student (+905392870087, fahrib@biruni.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity and Reliability of the Turkish IMBPIQ (time frame: Baseline and after 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.